- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02019862
TRJ Post Market Clinical Follow Up
April 15, 2015 updated by: Aesculap AG
TRJ PMCF Köln: 2-years Results
Clinical and radiological 2 years results of TRJ® Hip Stem.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Köln, Germany, 50933
- Dreifaltigkeitskrankenhaus Köln
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
specialist clinical centre
Description
Inclusion:
- TRJ® implantation performed
- patient consent available for participation in the study
Exclusion:
- permanent cortisone therapy
- alcohol or drug abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TRJ®
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Implant Survival
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Outcome
Time Frame: 24 months
|
Harris Hip Score
|
24 months
|
Osteolysis
Time Frame: 24 months
|
Radiological Outcome
|
24 months
|
Ossification
Time Frame: 24 months
|
Radiological Outcome
|
24 months
|
Migration
Time Frame: 24 months
|
Radiological Outcome
|
24 months
|
TRJ® Implant Position
Time Frame: 24 months
|
Radiological Outcome
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
December 4, 2013
First Submitted That Met QC Criteria
December 18, 2013
First Posted (Estimate)
December 24, 2013
Study Record Updates
Last Update Posted (Estimate)
April 16, 2015
Last Update Submitted That Met QC Criteria
April 15, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAG-O-H-1314
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Total Hip Arthroplasty
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
National Taiwan University HospitalUnknownTotal Hip Replacement | Total Hip ArthroplastyTaiwan
-
Northern Orthopaedic Division, DenmarkCompletedTotal Knee Arthroplasty | Total Hip ArthroplastyDenmark
-
Ortho Development CorporationOregon Health and Science UniversityEnrolling by invitationTotal Hip Replacement | Total Hip ArthroplastyUnited States
-
James A. KeeneyRecruitingPrimary Total Hip Arthroplasty | Primary Total Knee ArthroplastyUnited States
-
Musgrave Park HospitalBelfast Health and Social Care Trust; Queen's University, Belfast; Belfast Arthroplasty...CompletedTotal Hip Replacement | Total Hip Arthroplasty | THA | THRUnited Kingdom
-
Permedica spaNot yet recruitingTotal Hip ArthroplastyItaly
-
ExactechNot yet recruitingHip Arthroplasty, Total
-
Mauro CrestaniRecruitingTotal Hip ArthroplastyItaly
Clinical Trials on TRJ® Total Hip Arthroplasty
-
Aesculap AGActive, not recruiting
-
Aesculap AGActive, not recruitingRheumatoid Arthritis | Hip Dysplasia | Fractures, Hip | Necrosis, Femur Head | Coxarthrosis; Primary | Coxarthrosis; Post-TraumaticGermany
-
Smith & Nephew, Inc.RecruitingAdvanced Degeneration of the Hip Joint | Revision of the Hip JointUnited States, Canada, Australia, Hong Kong, India
-
Suzhou MicroPort OrthoRecon Co. LTDCompleted
-
Istituto Clinico HumanitasCompleted
-
DePuy OrthopaedicsTerminatedOsteoarthritis | Degenerative Arthritis | Revision ArthroplastyCanada
-
Rothman Institute OrthopaedicsCompleted
-
Orthopedic Hospital Vienna SpeisingCompletedTotal Hip ArthroplastyAustria
-
Western University, CanadaNot yet recruiting
-
Zimmer BiometTerminatedJoint Diseases | Osteoarthritis, Hip | Avascular Necrosis of Hip | Congenital Dysplasia of the Hip | Degenerative Joint Disease of Hip | Rheumatoid Arthritis of Hip | Post-Traumatic Osteoarthritis of HipCanada